EUCTR2011-000890-29-IT进行中(未招募)不适用
Instrumental and clinical effects of withdrawal of beta blockers therapy in patients with heart failure and right ventricular dysfunction'' - Destro
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR0 个研究点开始时间: 2012年3月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) age = 18 years, of both sexes 2) Presence of symptoms of congestive heart failure in particular belonging to NYHA II B class or higher 3) Presence of one or more signs of congestive heart failure: fluid retention (edema slopes, swelling of the jugular veins, ascites, anasarca), signs of reduced cardiac output (reduced functional capacity, fatigue) and, but not necessarily signs of pulmonary congestion (dyspnea, rales auscultation, pulmonary edema) 4) Presence of all of the following echocardiographic criteria: a) obvious left ventricular systolic dysfunction: EF = 45%, b) clear right ventricular systolic dysfunction (TDI S <10 cm / sec or TAPS <1.6 cm and FAC <35%); c) presence of pulmonary hypertension (PAPs = 40 mmHg) 5) Taking medication ceiling optimized for the treatment of heart failure for at least 1 month, this therapy must include a beta-blocker given on a continuous basis of the following approved for the treatment of heart failure: beta-1 selective (bisoprolol, metoprolol, nebivolol), nonselective (carvedilol).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Pulmonary embolism occurred in the 3 months period prior to enrollment 2) System of AICD-CRT made for less than 6 months from the date of enrollment 3)unstable angina or acute coronary syndrome in the month period prior to enrollment 4) hemodynamically significant arrhythmia (ventricular tachycardia, atrial fibrillation / atrial flutter with high ventricular response [> 130 bpm], atrioventricular block second degree Mobitz II or 3rd degree atrioventricular block, bradyarrhythmias [<45 bpm]) 5) severe renal insufficiency (GFR <15 mL/min/1.73 m2) 6) neoplasm in a non remission phase 7) Severe comorbidity so that they are expected to live less than one year 8) Taking beta-blocker therapy for prophylaxis of bleeding from esophageal varices
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